Alaska Injury Law Blog

Today's news is that gingko biloba, touted since the 1970's by the diet supplement industry as an herb that would improve memory or forestall cognitive decline in aging or in dementia, has been found to be useless. As routine scientific scrutiny has been applied to the nostrums of the industry in recent years, we see these "ancient healing" claims fall one by one: chondroitin and glucosamine for osteoarthritis, vitamin E and selenium for prostate cancer, or vitamin E and C for prevention of cancer or heart disease. (Indeed, recent studies have shown that the use of vitamin therapies can sometimes increase the risk of disease, as in folic acid increasing the risk for precancerous polyps or higher lung cancer rates for those trusting to beta carotene supplements.) When asked for data in support of their claims of efficacy, the industry simply trots out the claim that the Chinese have used the product for 5,000 years or that sharks never get cancer. By doing so, they seek to avoid the hard work of any scientific endeavor, i.e., proving that their product works.

As for the safety of these products, the industry has repeatedly picked the pockets of consumers with this magical thinking: "it is all-natural, so it has no side-effects but it works better than drugs." Of course, for a compound to work, it must have an effect, which means it is capable of affecting the body and causing side effects. It can't be effective and affect the body positively but never affect the body negatively. If it can affect the body at all, it is capable of having side effects, period. It is as if they were saying, "yes you can have the money and never pay taxes on it." Yet, we know that the IRS always gets its piece. And, herbals and diet supplements will always tax the body--there are always side effects.

We can't blame the industry, because we let them get away with selling billions of dollars of useless or dangerous or tainted products. We let Congress take money from the industry's lobbyists to pass DSHEA and dodge the effective regulation of the marketing and manufacturing of these products. We let the diet supplement industry tell consumers, "Ego exigo, proinde is est bonus,"...."I sell it, therefore it is good." We do not demand that the marketeers prove their case that a product is safe or efficacious, the simple standard the drug and OTC industries must meet.

Today's news comes to us from the Journal of the American Medical Association reporting on a study of over 3,000 people between 72 and 96 who were followed for over 6 years. None had dementia before the study began. Those who took the supplement fared no better than those who took a sugar pill in tests examining memory, language, attention, and other measures of cognitive function.

With annual sales of gingko biloba of over $250 million dollars, the industry could well afford to pay for its own testing for safety and efficacy. But, instead we paid for the testing with public funds. We let that happen, too.

Sources:

Snitz BE, et al "Ginkgo Biloba For Preventing Cognitive Decline In Older Adults" JAMA 2009; 302(24): 2663-70.

Diet Supplement Glucosamine No Better Than Placebo, February 20, 2008

New York Times, Extra Vitamin E: No Benefit, Maybe Harm, March 24, 2009

New York Times, Vitamin Pills: A False Hope?, February 16, 2009

As consumers, we have been repeatedly told that generic drugs are exact copies of their brand-name counterparts. We have been forced by insurers to accept generics over brand-name drugs. This is done by the insurer imposing financial disincentives and refusing to honor our physicians' prescriptions without getting the doctor's office to confirm the prescription. Pharmacies substitute generics for brand-name drugs without asking us first or telling us when they have made the switch. All the while there is an unsettling and nagging question in the back of our brains about whether generics are truly equivalent.

The FDA has taken the position that generics are equivalent, but the public is not informed about the agency's standard of review: a generic is deemed "bioequivalent" if it achieves 80 to 125% of what the brand-name drug provides. This is a huge variance, and one we don't accept in many human endeavors, whether we are talking about a pilot landing a plane or sending in what we owe to the IRS.

Indeed, specialists acknowledge a growing concern that patient experiences on generics are problematic, especially for those patients who have conditions that present significant risk of injury if chronic conditions are not properly treated, as in epilepsy or atrial fibrillation. For example, The American Academy of Neurology has released a position paper on generics, stating that: “The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval.”

If you take medications for a condition that has the risk of significant injury or death if your medications are not effective, you should discuss this concern about generics with your prescribing physician. Become an informed consumer about the generic drug you are being asked to take. And regardless what you are told, pay close attention to your symptoms and changes in your condition after taking generics so that you can determine from your own experience whether a generic drug is right for you.

Sources:
New York Times, Dec. 17, 2009

The People's Pharmacy, Dec. 17, 2009